Approval expands platinum-free treatment option for muscle-invasive bladder cancer patients regardless of cisplatin eligibility.
The FDA approved Pfizer and Astellas Pharma’s PADCEV plus Keytruda as a neoadjuvant and adjuvant treatment for muscle-invasive bladder cancer (MIBC) in adults. This marks the first platinum-free regimen approved for MIBC patients, regardless of cisplatin eligibility.
The decision follows Phase 3 EV-304 trial results presented at the 2026 ASCO Genitourinary Cancers Symposium. The expanded indication builds on a November 2025 approval for cisplatin-ineligible patients, based on EV-303 trial data published in the New England Journal of Medicine.
Bank of America lowered Pfizer’s price target to $26 from $27, maintaining a Neutral rating, while HSBC downgraded the stock to Hold from Buy with a $28 target, down from $32.